Study of STA-9090, Administered Twice-Weekly in Patients With Solid Tumors - Full Text View

Sponsor:	Synta Pharmaceuticals Corp.
Information provided by:	Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:	NCT00688116

Purpose

An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)

Condition	Intervention	Phase
Solid Tumors	Drug: STA 9090 (ganetespib)	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice-Weekly in Patients With Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:

The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities and evaluation of Adverse Events in relation to Study Drug. [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	45
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Intervention Details:

This is a dose-escalation study. The first cohort will consist of three patients who will receive 2 mg/m2 of STA 9090 (ganetespib) during a 1-hour infusion 2 times per week (e.g., [Monday, Thursday] or [Tuesday, Friday]) for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive 4, 7, 10, 14, 19, 25, 33, 40 and 48 mg/m2 provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Further dose increments will be approximately 20% over the previous dose level, until the maximum tolerated dose (MTD) is determined.

Detailed Description:

This is an open-label Phase 1 dose-escalation study in patients with solid tumors treated with STA-9090 (ganetespib) to evaluate for safety, tolerance and efficacy.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must be documented to be refractory or not candidates for current approved therapies. - Must have anECOG status 0-2. - Peripheral neuropathy ?2.
Must have acceptable organ and marrow function per protocol parameters.
No clinically significant ventricular arrythmias or ischemia.

Exclusion Criteria:

Must not be pregnant or breastfeeding. -No chemotherapy or radiation within 3 weeks..
No previous radiation to >25% of total bone marrow.
No previous high dose chemotherapy with autologous or allogeniec hematopoietic stem cell transplantation.
No primary brain tumors or active brain metastases.
No use of any investigational agents within 4 weeks.
No treatment with chronic immunosuppressants.
No uncontrolled, intercurrent illness.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688116

Locations

United States, Massachusetts
Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Elizabeth Ryer 617-632-6992 eryer@partners.org
Massachusetts General Hospital Cancer Center	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Natasha Isaac 617-726-6225
Beth Israel Deaconess Medical Center (BIDMC) - Cancer Center	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Myles Clancy 617-632-9280
United States, Michigan
Wayne State University/Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201
Contact: Dr. Patricia LoRusso 313-576-8716

Sponsors and Collaborators

Synta Pharmaceuticals Corp.

More Information

No publications provided

Responsible Party:	Robert Bradley/Clinical Trial Manager, Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:	NCT00688116 History of Changes
Other Study ID Numbers:	9090-01
Study First Received:	May 28, 2008
Last Updated:	July 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals Corp.:

metastatic cancer
solid tumor
histologically or cytologically confirmed non-hematological malignancy that is metastatic or unresectable
STA-9090
ganetespib

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012